Analytical Scientist, Physicochemical

Alvotech; India; Remote; INR 600,000 - 1,500,000; Full time

Job summary

Alvotech in India is seeking an experienced analytical scientist to support analytical development and characterization of biopharmaceuticals, including monoclonal antibodies. You will review data, write reports, and contribute to method qualification and validation.

The role involves assessing deviations, preparing assessments for comparability and stability, and collaborating across QA, Regulatory, and R&D teams.

Qualifications

• Degree in Chemistry, Biochemistry, Pharmaceutical Sciences or related field.
• Experience in analytical development, qualification or validation, quality control, or related biopharmaceutical activities.
• Strong knowledge of physicochemical methods such as HPLC/UHPLC, capillary electrophoresis and UV/Vis.
• Experience with analytical similarity, stability or characterization studies is an advantage.
• Strong scientific judgment, data interpretation and technical writing skills, with a good understanding of relevant ICH, FDA, USP and GMP requirements.

Responsibilities

• Review and critically assess analytical data, studies and technical documentation.
• Author and review method qualification and validation protocols and reports.
• Assess deviations, unexpected results and out of spec investigations arising during analytical studies.
• Prepare scientific reports and assessments supporting analytical similarity and comparability, stability, forced degradation and product characterization.
• Collaborate with laboratory scientists, Quality Assurance, Regulatory Affairs and other technical functions.

Skills

Analytical development

Data interpretation

Scientific writing

Quality control

Method review

Education

Bachelor's or Master's in Chemistry/Biochemistry/Pharmaceutical Sciences

Tools

HPLC/UHPLC

Capillary electrophoresis

UV/Vis

Job description

ABOUT THE ROLEWe are seeking an experienced analytical scientist to support analytical development and characterization of biological products, including monoclonal antibodies. This broad scientific role combines technical review, scientific writing, data interpretation and analytical development support.KEY RESPONSIBILITIESReview and critically assess analytical data, studies and technical documentation.Author and review method qualification and validation protocols and reports.Assess and document deviations, unexpected results and out of spec investigations arising during analytical studies.Prepare scientific reports and assessments supporting analytical similarity and comparability, stability, forced degradation and product characterization.Collaborate with laboratory scientists, Quality Assurance, Regulatory Affairs and other technical functions.QUALIFICATIONSDegree in Chemistry, Biochemistry, Pharmaceutical Sciences or related fields.Experience in analytical development, qualification or validation, quality control, or related biopharmaceutical activities.Strong knowledge of physicochemical methods such as HPLC/UHPLC, capillary electrophoresis and UV/Vis, preferably applied to monoclonal antibodies or other therapeutic proteins.Experience with analytical similarity, stability or characterization studies is an advantage.Strong scientific judgment, data interpretation and technical writing skills, with a good understanding of relevant ICH, FDA, USP and GMP requirements.